End Stage Renal DiseasePPSNCT00889291
HeRO Vascular Access Device Post Market Procedural Survey Protocol
An observational study of End Stage Renal Disease, run by Merit Medical Systems, Inc..
Trial summary
Post market observational survey of a vascular access device for access-challenged patients. Data collection efforts focused on patient medical and access history and implant procedure results. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- End Stage Renal Disease
- How many people
- 77 participants
- Where
- No sites listed yet
- Study dates
- Dec 2008to Jan 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: End stage renal disease patients requiring vascular access
Who may be able to join
- None
Who cannot join
- None
About this study
Post market observational survey of a vascular access device for access-challenged patients. Data collection efforts focused on patient medical and access history and implant procedure results.
Read the detailed description
Evaluation Design: This is a multi-center post market observational survey designed to collect procedural data on a minimum of 50 HeRO™ patients in the commercialization phase. Data will be collected retrospectively for patients already implanted with the HeRO™ device in the commercialization phase or prospectively for patients that receive the HeRO™ Device during the data collection period. No special patient screening, testing, or procedures are required. There is no required patient follow-up.
Subject Population: Any patients the investigator deems/deemed eligible for HeRO™ implant with complete procedural data are eligible for inclusion in this post market observational survey.
Endpoints: None
Inclusion/Exclusion Criteria: There are no formal screening criteria other than patients must have all required procedural data points available for recording on the case report form.
- Conditions
- End Stage Renal Disease
- Keywords
- End stage renal disease, Bacteremia, HeRO Vascular Access Device, Access challenged, Catheter dependent, End stage renal disease requiring vascular access. See HeRO device instructions for use for appropriate patient population
- Medical subject headings
- Kidney Failure, Chronic, Bacteremia
What is being measured
The primary outcome is the main question the study is designed to answer.
Device placement success
Measured: End of procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2009 (estimated)
- Study startDec 2008
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merit Medical Systems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marc Glickman, MD, Principal investigator, Sentara Heart Hospital, Norfolk, VA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00889291
- Sponsor's protocol ID
- 1-Abbs
- Acronym
- PPS
- Status last verified
- Aug 2017
- First submitted
- 9 Apr 2009
- Last updated
- 8 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HeRO Vascular Access Device Post Market Procedural Survey Protocol
- ClinicalTrials.gov ID
- NCT00889291
- Acronym / sponsor ID
- PPS / 1-Abbs
- Conditions
- End Stage Renal Disease
- Keywords
- End stage renal disease, Bacteremia, HeRO Vascular Access Device, Access challenged, Catheter dependent, End stage renal disease requiring vascular access. See HeRO device instructions for use for appropriate patient population
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Merit Medical Systems, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 28 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Post market observational survey of a vascular access device for access-challenged patients. Data collection efforts focused on patient medical and access history and implant procedure results.
Detailed description
Evaluation Design: This is a multi-center post market observational survey designed to collect procedural data on a minimum of 50 HeRO™ patients in the commercialization phase. Data will be collected retrospectively for patients already implanted with the HeRO™ device in the commercialization phase or prospectively for patients that receive the HeRO™ Device during the data collection period. No special patient screening, testing, or procedures are required. There is no required patient follow-up.
Subject Population: Any patients the investigator deems/deemed eligible for HeRO™ implant with complete procedural data are eligible for inclusion in this post market observational survey.
Endpoints: None
Inclusion/Exclusion Criteria: There are no formal screening criteria other than patients must have all required procedural data points available for recording on the case report form.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- End stage renal disease patients requiring vascular access
Key inclusion criteria (1 listed)
- None
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Device placement success
Time frame: End of procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2017.
- Additional information regarding the HeRO Vascular Access DeviceLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc Glickman, MD principal investigator
Sentara Heart Hospital, Norfolk, VA
Questions about this trial
What is this clinical trial studying?
An observational study of End Stage Renal Disease, run by Merit Medical Systems, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device placement success (time frame: End of procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2017.